CTRI/2023/08/056078尚未招募Unknown
A Multi-center, Multi-national, Prospective Surveillance Study of RespiratorySyncytial Virus Disease in Infants & Toddlers 6 to less than 22 Months of Age - nil
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Participants are eligible for the study only if all of the following criteria are met:
- •I01: Aged 6 months to < 22 months on the day of inclusion
- •Type of participant and disease characteristics
- •I02: Participants who are healthy as determined by medical evaluation including medical
- •I03: Born at full term of pregnancy (>= 37 weeks) or born after a gestation period of
- •27 through 36 weeks and medically stable as assessed by the investigator, based on the
- •following definition: â??Medically stable ? refers to the condition of premature infants who
- •do not require significant medical support or ongoing management for debilitating
- •disease and who have demonstrated a clinical course of sustained recovery by the time
- •they are enrolled in the study
- •Informed Consent
- •Informed consent form has been signed and dated by the parent(s) or other LAR (and by
- •an independent witness if required by local regulations)
- •OTHER INCLUSIONS
- •I05: Participant and parent/LAR are able to attend all scheduled visits and to comply with all
- •study procedures
排除标准
- •Participants are not eligible for the study if any of the following criteria are met:
- •Medical conditions
- •E01: Known or suspected congenital or acquired immunodeficiency; or receipt of
- •immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
- •within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone
- •or equivalent for more than 2 consecutive weeks within the past 3 months)
- •E02: Chronic illness that, in the opinion of the investigator, is at a stage where it might
- •interfere with study conduct or completion.
- •E03: Probable or confirmed ongoing case of viral respiratory infection (including COVID-19,
- •influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not
- •be included in the study until the respiratory infection has resolved
- •E04: Member of a household that contains an immunocompromised individual, including, but
- •not limited to:
- •a person who is human immunodeficiency virus (HIV) infected
- •a person who has received chemotherapy within the 12 months prior to study
- •a person who has received (within the past 6 months) or is receiving (at the time of
- •enrollment) immunosuppressant agents
- •a person living with a solid organ or bone marrow transplant
- •Prior/concomitant therapy
- •E05: Participantâ??s mother previous receipt or planned administration of an investigational
- •RSV vaccine during pregnancy and/or breastfeeding
- •E06: Receipt or planned receipt of any of the following vaccines:
- •Any intranasal live attenuated vaccine within the 28 days prior to enrollment
- •Any injectable live attenuated vaccine within the 28 days prior to and after
- •E07: Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product
- •(such as ribavirin or RSV immune globulin or RSV monoclonal antibody) less than
- •6 months before enrollment
- •E08: Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •Prior/concurrent clinical study experience
- •E09: Participation at the time of study enrollment or planned participation during the present
- •study period in another clinical study investigating a vaccine, drug, medical device, or
- •medical procedure
- •Other exclusions
- •E10: Deprived of freedom in an emergency setting, or hospitalized involuntarily
- •E11: Identified as a natural or adopted child of the Investigator or employee with direct
- •involvement in the proposed study
- •If the participant has a primary physician who is not the investigator, the site should contact this
- •physician with the participantâ??s parents / LARâ??s consent to inform this physician of the
- •participantâ??s participation in the study. In addition, the site should ask this primary physician to
- •verify exclusion criteria relating to previous therapies, such as receipt of blood products or
- •previous vaccines.
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